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NCT Number: NCT06997029

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

Recruiting

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Key information

Conditions

Advanced Solid Tumor Advanced Breast Cancer Advanced Ovarian Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Odense Universitetshospital, Odense, Region Syddanmark, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be ≥ 18 years of age.
  • Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
  • Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • For Part 2A only, participants must have CCNE1-amplified ovarian cancer

Exclusion criteria

  • Participants must not have an active brain metastasis.
  • Participants must not have impaired cardiac function or clinically significant cardiac disease.
  • Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
  • Participants must not have Grade ≥ 2 peripheral neuropathy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986500

Drug

Specified dose of specified days

Palbociclib

Drug

Specified dose on specified days

Other names: IBRANCE®, PD 0332991

Fulvestrant

Drug

Specified dose on specified days

Other names: FASLODEX®

Primary outcomes

  1. Number of Participants With Dose Limiting Toxicities (DLTs)

    Time frame: Up to Day 28 From Last Dose

  2. Number of Participants With Adverse Events (AEs)

    Time frame: Up to Day 28 From Last Dose

  3. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to Day 28 From Last Dose

  4. Number of Participants With AEs Leading to Discontinuation

    Time frame: Up to Day 28 From Last Dose

  5. Number of Participants With TEAEs Leading to Death

    Time frame: Up to Day 28 From Last Dose

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of BMS-986500

    Time frame: Up to Approximately 2 Years

  2. Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500

    Time frame: Up to Approximately 2 Years

  3. Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500

    Time frame: Up to Approximately 2 Years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 30, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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